Rethinking India’s regulatory framework to foster new investments in medical devices
The government aims to transform India into a global manufacturing hub. Representative Image
By Abby Pratt
As the world is fighting the pandemic, new dynamics are taking shape in the way global supply chains function. From Japan paying its companies to shut their manufacturing plants in China to American companies planning to shift base, these are times of strategic transitions. For a country with the fourth-largest medical devices foothold in Asia, looking to grow to $50 billion by 2025, India must aim to increase local investment and production.
While India’s aim to be self-reliant is promising, what will define its success is the regulatory framework in medical devices. In 2017, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare (MoHFW) issued the Medical Devices Rules, 2017, which were generally aligned and harmonised with the guidance documents and framework established by the International Medical Device Regulators Forum (IMDRF)—formerly the Global Harmonization Task Force (GHTF).
In 2019, there were reports of a Medical Devices Bill being developed by the NITI Aayog, and the highlights were shared with the industry, which, the industry reports, are not aligned with globally-accepted harmonised regulatory practices. Industry representatives recommended that any new legislation should be aligned with international regulatory best practices and the industry should be involved and consulted throughout the process.
In 2017, we saw the genesis of voluntary certifications like the Indian Certification for Medical Devices (ICMED) by the Quality Council of India, giving process certification to many medical devices using notified bodies. The industry could not comprehend the need for the voluntary certification scheme, and this was opposed by the CII and the FICCI. Medical device experts see it as a deviation from global practices.
This indicates the regulatory environment in India has been made complex and it needs to be evaluated how such initiatives will reduce costs, help Indian manufacturers increase medical device exports, and establish trust amongst consumers in India and globally.
The government aims to transform India into a global manufacturing hub. If the regulatory mechanism is not harmonised with global best practices as recommended by the IMDRF, Indian manufacturers will find it difficult and would have to look for better economies that have regulations harmonised with the IMDRF.
Compliance with global standards
Essential principles of safety and performance are important. To demonstrate compliance with essential principles, we have consensus standards such as those developed by global standards bodies such as the ISO and the IEC, and recognised by stringent regulatory authorities as well as the IMDRF. There are two kinds of standards: horizontal (ones that describe the process or practice that is applied across a range of devices, like sterilisation, software, etc) and vertical (specific test methods or performance aspects of a specific grouping of devices). These standards have been segregated so that a manufacturer can develop a medical device in accordance with key elements of essential principles.
Procurement agencies have been procuring commodities complying with a specific standard; in the case of medical devices, they were faced with the challenge in procurement as the same product with different specifications and varying complexities was before them and this led to complexities in procurement. Hence, the Bureau of Indian Standards (BIS) was requested to develop standards to procure medical devices without understanding that first-generation devices and fifth-generation devices will be viewed with the same lens.
The BIS must adopt international standards to encourage Indian manufacturers to conquer the global market as well as help global players introduce new products and increase investments in India. The US, the EU, Japan and other IMDRF countries rely on these consensus standards to increase predictability, streamline premarket review and provide clearer regulatory expectations.
The move to create India-specific standard also tends to isolate Indian products from global markets. At a time when the country is going strong on the self-reliant perspective, we must look at these regulatory exercises more closely.
The author is vice-president, Global Strategy & Analysis, AdvaMed (Advanced Medical Technology Association)